Intraoperative Hyperoxia and MINS

NCT ID: NCT04540276

Last Updated: 2021-02-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

7700 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-02-04

Study Completion Date

2021-03-01

Brief Summary

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Oxygen therapy is administered to all patients during general anesthesia to maintain tissue oxygenation and prevent hypoxia and ischemia. However, liberal use of oxygen may lead to hyperoxia and some studies suggest that supranormal levels of arterial oxygen saturation may lead to complications. In this post hoc substudy of the VISION cohort, we plan to assess the association between perioperative inspired oxygen fraction (FiO2) and myocardial injury after non-cardiac surgery (MINS).

Detailed Description

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Patients will be divided into five groups of median intraoperative FiO2 (quintiles), in which baseline characteristics and outcomes will be illustrated.

The odds ratio (OR) for the primary and secondary outcomes will be calculated in a logistic regression analysis with median FiO2 (continuous variable) as independent variable.

Analyses are performed with multiple logistic regression with adjustment for the following potentially confounding variables:

Age ≥75 years. Male sex. Current atrial fibrillation. History of diabetes. History of congestive heart failure. History of coronary artery disease. History of recent (i.e., \< 6 months) high-risk coronary artery disease. History of stroke. History of peripheral vascular disease. History of hypertension. Preoperative eGFR (\<30 vs. 30-44 vs. 45-59 vs. ≥60 mL/min/1.73m2). Low-risk surgery. Duration of surgery.

Conditions

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Hyperoxia Myocardial Infarction Myocardial Injury

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

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Inspiratory oxygen fraction

Median inspiratory oxygen fraction during general anesthesia

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients entered in the VISION database, aged 18 years or above, undergoing noncardiac surgery in general anesthesia.

Exclusion Criteria

* Patients with unobtainable data on perioperative FiO2.
* Patients with unobtainable data on postoperative troponin.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Population Health Research Institute

OTHER

Sponsor Role collaborator

University Hospital Bispebjerg and Frederiksberg

OTHER

Sponsor Role lead

Responsible Party

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Sofie Pedersen

MD, PhD-student at Dept. of Anesthesia and Intensive Care

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Christian S. Meyhoff, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University hospital Bispebjerg Frederiksberg

PJ Devereaux, MD, PhD

Role: STUDY_CHAIR

Population Healt Research Institute

Locations

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Cleveland Clinic

Cleveland, Ohio, United States

Site Status

Walter C. Mackenzie Health Sciences Centre

Edmonton, , Canada

Site Status

Prince of Wales Hospital

Hong Kong, , China

Site Status

Foundation CardioInfanil

Bogotá, , Colombia

Site Status

Bispebjerg Hospital

Copenhagen, NV, Denmark

Site Status

Christian Medical College

Ludhiāna, , India

Site Status

University Malaya Medical Centre

Kuala Lumpur, , Malaysia

Site Status

Inkosi Albert Luthuli Hospital

Durban, , South Africa

Site Status

Countries

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United States Canada China Colombia Denmark India Malaysia South Africa

Other Identifiers

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Hyperoxia and MINS

Identifier Type: -

Identifier Source: org_study_id

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